新生血管性加齢黄斑変性症および糖尿病黄斑浮腫を有する日本人患者におけるアフリベルセプトの日常診療での使用についてさらに詳しく知るための研究

基本情報

NCT ID

NCT06929143

ステータス

実施中（募集終了）

試験のフェーズ

-

試験タイプ

観察

目標被験者数

3,000

治験依頼者名

Bayer

概要

This is an observational study in which data already collected from participants with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) is studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare. The eye disorders, nAMD and DME, affect the macula, the central part of the retina at the back of the eye. This leads to blurry vision or blind spots, making everyday activities like reading or sewing difficult. While nAMD is linked to aging, DME is related to diabetes. Both conditions require similar treatment to help improve vision. Aflibercept 8 milligrams (mg) is already approved in Japan for doctors to prescribe to people with nAMD or DME. It is a drug injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF), which causes abnormal growth and leakage of blood vessels at the back of the eye. The participants in this study are already receiving treatment with aflibercept 8 mg as part of their regular care from their doctors. There is limited data available on the use of aflibercept 8 mg in Japan. Data from routine medical practice will inform treatment in Japanese and other Asian populations. The main purpose of this study is to learn more about the disease and patient characteristics of Japanese participants with nAMD and/or DME who receive aflibercept 8 mg during their routine healthcare, and how they use it. To learn this, the study will use 2 methods: Method 1: Researchers will study the health details of participants when they first started aflibercept 8 mg. Method 2: Researchers will study the participants' data collected over 1 year to see how they used aflibercept 8 mg. The data will come from a claims database called DeSC Healthcare Inc. The data will be collected from April 2023 to March 2025 for Method 1, and from April 2023 to March 2026 for Method 2. Researchers will only look at the information from participants in Japan. In this study, only available data from routine care are collected. No visits or tests are required as part of this study.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)